Could Investigator Databank Provide a Central Repository for CVs?

Applied Clinical Trials reported this week news that Janssen Research & Development are establishing a global, cross-pharmaceutical Investigator Databank to improve the efficiency of industry-sponsored clinical trials. The Investigator Databank, to be hosted by DrugDev.org, will hold key information about clinical investigator sites including their infrastructure and “good clinical practice (GCP) training records”.

As these types of initiatives are developed and become more commonplace, it remains to be seen whether the expectation of regulatory inspectors will be that the industry sponsors maintains a copy of training records and CVs for trial staff, or whether it would be acceptable to cite the Investigator Databank as the official repository for such information. The latter would certainly remove one of the administrative burdens of managing trials, namely ensuring that an up-to-date CV is on file for key trial site personnel. It would of course be necessary to have certain guarantees that the records held at DrugDev.org were kept up-to-date and retained for the required period of time.

As collaborative efforts across industry increase, I’m sure we’ll see more of these issues arising. The challenge will be whether or not regulatory authorities and industry can accommodate a paradigm shift in terms of record maintenance and ownership.

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About rammellel

Records management consultant to the life sciences / pharmaceutical industry
This entry was posted in Compliance, Records management practice, TMF and tagged , . Bookmark the permalink.

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